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Principal Device Quality Engineer at Heartflow - ApplyBlast

Principal Device Quality Engineer

Heartflow

1 month ago

3.0 on Glassdoor

San Francisco, California, United States

Hybrid

Full Time

Senior

1 applicant

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About this role

The Principal Device Quality Engineer at Heartflow will serve as the global subject matter expert for software quality and design excellence, bridging rapid Agile development with stringent medical device regulations. This role oversees compliance throughout the software development lifecycle, including architecture, security, risk management, verification and validation, and regulatory submissions for AI/ML-enabled medical technologies.

Responsibilities

Lead integration of modern technologies into the Quality Management System
Oversee Design History File compliance from concept to commercialization
Represent software QMS during FDA and external audits

Skills

Qualifications

Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or related fieldMaster's degreeASQ Certified Quality Engineer (CQE)Certified Software Quality Engineer (CSQE)Six Sigma Black Belt

About Heartflow

heartflow.com

Headquarters

San Francisco, California, United States

Company Size

201-500 employees

Founded

2010

View Profile

Heartflow, headquartered in San Francisco, California, is a health technology company focused on transforming coronary artery disease (CAD) diagnosis and long-term management. Its AI-powered Heartflow One platform converts coronary CT angiography (CCTA) scans into detailed, patient-specific 3D models of the heart, offering tools including FFRCT Analysis for blood flow assessment, Roadmap Analysis for CAD detection, Plaque Analysis for disease quantification and risk stratification, and a PCI Navigator for intervention planning. Deployed across more than 1,800 institutions globally, Heartflow aims to improve diagnostic accuracy, personalize treatment pathways, and reduce unnecessary invasive procedures.